Respond Effectively to FDA ... or else! - Jan 29, 2008

Here's another Warning Letter issued by FDA for an inadequate response to a Form FDA 483, List of Inspectional Observations. This one was issued to Noven Pharmaceuticals, Inc. on Jan 4 - right after the holidays.

It is critical that we not only develop good, effective, science-based responses to an FDA inspection, but then implement what you said you would do. ESPECIALLY if you receive a Warning Letter - because you know the FDA will be back to reinspect after issuing a Warning Letter.

Read the letter issued to Noven. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1332 clients since 1996

Last call - GMP Boot Camp Feb 13-14
Fundamentals of GMP/QSR Anaheim, CA
www.gmptrainingsystems.com/asp/Public_workshops.asp

GMP for Dietary Supplements web seminar Feb 8
www.gmptrainingsystems.com/asp/GMP_store_080208.asp

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Systems Thinking discussion with Russ Ackoff - Jan 21, 2008

David Markovitz, President of GMP Training Systems, Inc. here with some Breaking News!

Russ Ackoff, PhD is often referred to as the "Father of Systems Thinking." He's reached the age of 88 and still teaching and writing. I've had the privilege of spending a day with Dr. Ackoff in 2004 and I still refer to my notes from that day. With FDA's emphasis on a Systems-based Approach to their Inspections, there is a lot to learn from someone like Ackoff.

There is a discussion via teleconference with Dr. Ackoff on Jan 24 and 25 (2 hours each day) and you can participate at no charge. The InThinking Network is sponsoring this FREE seminar with Dr. Ackoff. This is possible through an arrangement they have with Pratt and Whitney/Rocketdyne and the Boeing Corp. (It helps to have a rich patron.)

For details, go to:
www.gmptrainingsystems.com/asp/Ackoff.asp

We've posted four articles by Dr. Ackoff for you to download with our compliments. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Personal Productivity and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1331 clients since 1996

GMP Boot Camps 2008
Fundamentals of GMP for FDA Regulated Industries
Feb 13 - 14 Anaheim/Newport Beach, CA
GMP for Dietary Supplements New for 2008
Mar 19-20 Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/Public_workshops.asp

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Effective Response to FDA 483 is Critical - Jan 14, 2008

After an FDA inspection resulting in the issuance of a Form FDA 483, List of Inspectional Observations, it is CRITICAL to respond to the FDA EFFECTIVELY. If you don’t, it could and often does lead to serious consequences.

Recently a company received a Warning Letter (just before Christmas) because of their inadequate response.

To read this Warning Letter issued to G. Dundas Company, Inc., go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

One issue they were cited for: “You could not provide written training procedures during the inspection and a training record for an employee who has been employed for six months.”

GMP Tip

Lack of written training procedures and training documentation can lead to a Warning Letter. This is so easy to do that it should never be cause for a Warning Letter. But it takes resources and commitment to get it done.

Does your company have the resources necessary for compliance?

Does your company have the commitment to make cGMP compliance a priority?

Does your company invest the time to prepare an effective response to a 483, and then follow through with implementation?

If you answered no to any of these questions, you might want to share this Warning Letter with your management team.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1329 clients since 1996

GMP Boot Camps 2008
Fundamentals of GMP for FDA Regulated Industries
Feb 13 - 14 Anaheim/Newport Beach, CA
GMP for Dietary Supplements New for 2008
Mar 19-20 Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/Public_workshops.asp

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Innovate in 2008 - Jan 8, 2008

Leading edge organizations practice innovation as a way of life. This is particularly challenging in heavily regulated industries. Learning how to make innovation happen in this environment requires understanding innovation in more than one context.

Here's another short e-book entitled "The Six Core Values of Innovation" that addresses this issue succinctly. It's our New Year's gift to you so you can get a great start in 2008.

Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Personal Productivity.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1323 clients since 1996

GMP Boot Camps 2008
Fundamentals of GMP for FDA Regulated Industries
Feb 13 - 14 Anaheim/Newport Beach, CA
GMP for Dietary Supplements New for 2008
Mar 19-20 Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/Public_workshops.asp

Please forward this post to others in your organization who might benefit.

Innovation: More Than a New Year's Resolution - Jan 2, 2008

Happy New Year!

"Innovation is defying complacency by continually seeking and seizing improvements, one scenario at a time." from Innovation: More Than a New Year's Resolution.

Get a great start in 2008 by reading this terrific little e-book on Innovation. Download it now as our New Year's gift to you. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Personal Productivity.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1319 clients since 1996

GMP Boot Camps 2008
Fundamentals of GMP for FDA Regulated Industries
Feb 13 - 14 Anaheim/Newport Beach, CA
GMP for Dietary Supplements New for 2008
Mar 19-20 Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/Public_workshops.asp

Please forward this post to others in your organization who might benefit.